Identity
- Trade Name
- American Red Cross FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- Intended Use This thermometer is intended to measure core body temperature of infants and adults through the ear. It can also measure surface temperatures of objects like baby bottles. Advantages of Using an Ear Thermometer The eardrum shares blood supply with the hypothalamus which makes for a more accurate reading than other body parts. FDA UDI
- Model / Reference
- DET-103 FDA UDI
- Description
- Intended Use This thermometer is intended to measure core body temperature of infants and adults through the ear. It can also measure surface temperatures of objects like baby bottles. Advantages of Using an Ear Thermometer The eardrum shares blood supply with the hypothalamus which makes for a more accurate reading than other body parts. FDA UDI
Identifiers
- Catalog Number
- AR3103 FDA UDI
- Primary DI / UDI-DI
- 84617503103019 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, ear
American Red Cross by Creative Concepts Manufacturing Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Creative Concepts Manufacturing Limited
Sources (1)
- FDA UDI cc336fae-2104-4eed-95df-c7bd4b131bfe 35 fields · synced Jun 8, 2026